Dive Brief:
- Empatica is preparing to run a clinical study to support the development of an algorithm that forecasts seizures for people with epilepsy.
- The study will use a wearable device to capture real-world data that could help understand and predict seizures, potentially leading to an algorithm that provides early warnings and alerts.
- Empatica, which plans to start enrolling subjects early next year, is building on earlier milestones such as the 510(k) clearance of a smartwatch for detecting possible convulsive seizures.
Dive Insight:
The creation of wearable devices capable of monitoring variables such as the rate and electrical activity of the heart, coupled with the rise of artificial intelligence and machine learning, has spurred the development of technologies designed to predict epileptic seizures. Empatica is part of the push, securing clearance from the Food and Drug Administration for its Embrace device in 2018.
Embrace, a wrist-worn wearable, senses electrodermal activity and motion to detect patterns that may be associated with seizures. When the system detects a seizure pattern, it alerts a designated caregiver.
In the new study, Empatica will use its FDA-cleared wearable to help “identify individualized periods of seizure risk for patients with epilepsy, using biomarker viability and patterns in patient lifestyle data as inputs to a forecasting algorithm,” the company said in a statement. The study could help address an unmet need, as Rosalind Picard, co-founder and chief scientist at Empatica, explained.
“Seizure forecasting has long been among the most-requested features for people with epilepsy,” Picard said in a statement. “Patients with epilepsy understand the toll that uncertainty around seizures takes and we hope that this study will help give them better control over their life, reducing stress and perhaps also enabling early interventions that ultimately reduce or prevent seizures from happening.”
The study will build on Empatica’s work on hardware and software. As well as developing Embrace, the digital health company has worked on predictive algorithms powered by AI. The work on AI led to the release of a CE-marked algorithm designed to detect early signs of COVID-19 and other respiratory infections.